Methods for controlling the internal circumference of an anatomic orifice or lumen

ABSTRACT

A method for controlling the circumference of internal anatomic passages corrects physiologic dysfunctions resulting from a structural orifice or lumen which is either too large or too small. Implants are disclosed which employ various means for adjusting and maintaining the size of an orifice to which they are attached. Systems permit the implants to be implanted using minimally invasive procedures and permit final adjustments to the circumference of the implants after the resumption of normal flow of anatomic fluids in situ. Methods are disclosed for using the implants to treat heart valve abnormalities, gastroesophageal abnormalities, anal incontinence, and the like.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. patent application Ser. No.10/651,851 (filed Aug. 29, 2003), which claims priority under 35 U.S.C.§119(e) to U.S. Provisional Patent Applications Nos. 60/406,841 (filedon Aug. 29, 2002), 60/444,005 (filed on Jan. 31, 2003) and 60/447,383(filed on Feb. 14, 2003) and 60/462,435 (filed Apr. 12, 2003).

TECHNICAL FIELD

The present invention relates generally to surgical procedures andrelates more specifically to surgical procedures for controlling theinternal circumference of an anatomic orifice or lumen.

BACKGROUND OF THE INVENTION

Many anatomic structures in the mammalian body are hollow passages inwhich walls of tissue define a central lumen, which serves as a conduitfor blood, other physiologic fluids, nutrient matter, or waste matterpassing within the structure. In many physiologic settings, dysfunctionmay result from a structural lumen which is either too large or toosmall. In most such cases, dysfunction can be relieved by interventionalchanges in the luminal size.

Thus in surgery, there is often a need to reduce the internalcircumference of an orifice or other open anatomic structure to narrowthe size of the orifice or opening to achieve a desired physiologiceffect. Often, such surgical procedures require interruption in thenormal physiologic flow of blood, other physiologic fluids, or otherstructural contents through the orifice or structure. The exact amountof the narrowing required for the desired effect often cannot be fullyappreciated until physiologic flow through the orifice or structure isresumed. It would be advantageous, therefore, to have an adjustablemeans of achieving this narrowing effect, such that the degree ofnarrowing could be changed after its implantation, but after theresumption of normal flow in situ.

One example of a dysfunction within an anatomic lumen is in the area ofcardiac surgery, and specifically valvular repair. Approximately onemillion open heart surgical procedures are now performed annually in theUnited States, and twenty percent of these operations are related tocardiac valves.

The field of cardiac surgery was previously transformed by theintroduction of the pump oxygenator, which allowed open heart surgery tobe performed. Valvular heart surgery was made possible by the furtherintroduction of the mechanical ball-valve prosthesis, and manymodifications and different forms of prosthetic heart valves have sincebeen developed. However, the ideal prosthetic valve has yet to bedesigned, which attests to the elegant form and function of the nativeheart valve. As a result of the difficulties in engineering a perfectprosthetic heart valve, there has been growing interest in repairing apatient's native valve. These efforts have documented equal long-termdurability to the use of mechanical prostheses, with added benefits ofbetter ventricular performance due to preservation of the subvalvularmechanisms and obviation of the need for chronic anticoagulation. Mitralvalve repair has become one of the most rapidly growing areas in adultcardiac surgery today.

Mitral valve disease can be subdivided into intrinsic valve disturbancesand pathology extrinsic to the mitral valve ultimately affectingvalvular function. Although these subdivisions exist, many of the repairtechniques and overall operative approaches are similar in the variouspathologies that exist.

Historically, most valvular pathology was secondary to rheumatic heartdisease, a result of a streptococcal infection, most commonly affectingthe mitral valve, followed by the aortic valve, and least often thepulmonic valve. The results of the infectious process are mitralstenosis and aortic stenosis, followed by mitral insufficiency andaortic insufficiency. With the advent of better antibiotic therapies,the incidence of rheumatic heart disease is on the decline, and accountsfor a smaller percentage of valvular heart conditions in the developedworld of the present day. Commissurotomy of rheumatic mitral stenosiswas an early example of commonly practiced mitral valve repair outsideof the realm of congenital heart defects. However, the repairs ofrheumatic insufficient valves have not met with good results due to theunderlying valve pathology and the progression of disease.

Most mitral valve disease other than rheumatic results in valvularinsufficiency that is generally amenable to repair. Chordae rupture is acommon cause of mitral insufficiency, resulting in a focal area ofregurgitation. Classically, one of the first successful and acceptedsurgical repairs was for ruptured chordae of the posterior mitralleaflet. The technical feasibility of this repair, its reproducible goodresults, and its long-term durability led the pioneer surgeons in thefield of mitral valve repair to attempt repairs of other valvepathologies.

Mitral valve prolapse is a fairly common condition that leads over timeto valvular insufficiency. In this disease, the plane of coaptation ofthe anterior and posterior leaflets is “atrialized” relative to a normalvalve. This problem may readily be repaired by restoring the plane ofcoaptation into the ventricle.

The papillary muscles within the left ventricle support the mitral valveand aid in its function. Papillary muscle dysfunction, whether due toinfarction or ischemia from coronary artery disease, often leads tomitral insufficiency (commonly referred to as ischemic mitralinsufficiency). Within the scope of mitral valve disease, this is themost rapidly growing area for valve repair. Historically, only patientswith severe mitral insufficiency were repaired or replaced, but there isincreasing support in the surgical literature to support valve repair inpatients with moderate insufficiency that is attributable to ischemicmitral insufficiency. Early aggressive valve repair in this patientpopulation has been shown to increase survival and improve long-termventricular function.

In addition, in patients with dilated cardiomyopathy the etiology ofmitral insufficiency is the lack of coaptation of the valve leafletsfrom a dilated ventricle. The resultant regurgitation is due to the lackof coaptation of the leaflets. There is a growing trend to repair thesevalves, thereby repairing the insufficiency and restoring ventriculargeometry, thus improving overall ventricular function.

The two essential features of mitral valve repair are to fix primaryvalvular pathology (if present) and to support the annulus or reduce theannular dimension using a prosthesis that is commonly in the form of aring or band. The problem encountered in mitral valve repair is thesurgeon's inability to fully assess the effectiveness of the repairuntil the heart has been fully closed, and the patient is weaned offcardiopulmonary bypass. Once this has been achieved, valvular functioncan be assessed in the operating room using transesophagealechocardiography (TEE). If significant residual valvular insufficiencyis then documented, the surgeon must re-arrest the heart, re-open theheart, and then re-repair or replace the valve. This increases overalloperative, anesthesia, and bypass times, and therefore increases theoverall operative risks.

If the prosthesis used to reduce the annulus is larger than the idealsize, mitral insufficiency may persist. If the prosthesis is too small,mitral stenosis may result. The need exists, therefore, for anadjustable prosthesis that would allow a surgeon to adjust the annulardimension in situ in a beating heart under TEE guidance or otherdiagnostic modalities to achieve optimal valvular sufficiency andfunction.

Cardiac surgery is but one example of a setting in which adjustment ofthe annular dimension of an anatomic orifice in situ would be desirable.Another example is in the field of gastrointestinal surgery, where theNissen fundoplication procedure has long been used to narrow thegastro-esophageal junction for relief of gastric reflux into theesophagus. In this setting, a surgeon is conventionally faced with thetension between creating sufficient narrowing to achieve reflux control,but avoiding excessive narrowing that may interfere with the passage ofnutrient contents from the esophagus into the stomach. Again, it wouldbe desirable to have a method and apparatus by which the extent to whichthe gastro-esophageal junction is narrowed could be adjusted in situ toachieve optimal balance between these two competing interests.

Aside from the problem of adjusting the internal circumference of bodypassages in situ, there is often a need in medicine and surgery to placea prosthetic implant at a desired recipient anatomic site. For example,existing methods proposed for percutaneous mitral repair includeapproaches through either the coronary sinus or percutaneous attempts toaffix the anterior mitral leaflet to the posterior mitral leaflet.Significant clinical and logistical problems attend both of theseexisting technologies. In the case of the coronary sinus procedures,percutaneous access to the coronary sinus is technically difficult andtime consuming to achieve, with procedures which may require severalhours to properly access the coronary sinus. Moreover, these proceduresemploy incomplete annular rings, which compromise their physiologiceffect. Such procedures are typically not effective for improving mitralregurgitation by more than one clinical grade. Finally, coronary sinusprocedures carry the potentially disastrous risks of either fatal tearsor catastrophic thrombosis of the coronary sinus.

Similarly, percutaneous procedures which employ sutures, clips, or otherdevices to affix the anterior mitral leaflets to the posterior mitralleaflets also have limited reparative capabilities. Such procedures arealso typically ineffective in providing a complete repair of mitralregurgitation. Furthermore, surgical experience indicates that suchmethods are not durable, with likely separation of the affixed valveleaflets. These procedures also fail to address the pathophysiology ofthe dilated mitral annulus in ischemic heart disease. As a result of theresidual anatomic pathology, no ventricular remodeling or improvedventricular function is likely with these procedures.

The need exists, therefore, for a delivery system and methods for itsuse that would avoid the need for open surgery in such exemplarycircumstances, and allow delivery, placement, and adjustment of aprosthetic implant to reduce the diameter of such a mitral annulus in apercutaneous or other minimally invasive procedure, while stillachieving clinical and physiologic results that are at least theequivalent of the yields of the best open surgical procedures for thesesame problems.

The preceding cardiac applications are only examples of someapplications according to the present invention. Another exemplaryapplication anticipated by the present invention is in the field ofgastrointestinal surgery, where the aforementioned Nissen fundoplicationprocedure has long been used to narrow the gastro-esophageal junctionfor relief of gastric reflux into the esophagus. In this setting, asurgeon is conventionally faced with the tension between creatingsufficient narrowing to achieve reflux control, but avoiding excessivenarrowing that may interfere with the passage of nutrient contents fromthe esophagus into the stomach. Additionally, “gas bloat” may cause theinability to belch, a common complication of over-narrowing of the GEjunction. An adjustable prosthetic implant according to the presentinvention could allow in situ adjustment in such a setting underphysiologic assessment after primary surgical closure. Such anadjustable prosthetic implant according to the present invention couldbe placed endoscopically, percutaneously, or with an endoscope placedwithin a body cavity or organ, or by trans-abdominal or trans-thoracicapproaches. In addition, such an adjustable prosthetic implant accordingto the present invention could be coupled with an adjustment meanscapable of being placed in the subcutaneous or other anatomic tissueswithin the body, such that remote adjustments could be made to theimplant during physiologic function of the implant. This adjustmentmeans can also be contained within the implant and adjusted remotely,i.e. remote control adjustment. Such an adjustment means might becapable of removal from the body, or might be retained within the bodyindefinitely for later adjustment.

The present invention and the methods for its use anticipate manyalternate embodiments in other potential applications in the broadfields of medicine and surgery. Among the other potential applicationsanticipated according to the present invention are adjustable implantsfor use in the treatment of morbid obesity, urinary incontinence,anastomotic strictures, arterial stenosis, urinary incontinence,cervical incompetence, ductal strictures, and anal incontinence. Thepreceding discussions are intended to be exemplary embodiments accordingto the present invention and should not be construed to limit thepresent invention and the methods for its use in any way.

SUMMARY OF THE INVENTION

In a first aspect, the present invention is directed to a novelprosthetic implant and method for use for adjusting the internalcircumference of an anatomic passage that can be adjusted afterimplantation but after the resumption of normal flow of anatomic fluidsin situ. In another aspect, the present invention is directed to a noveldelivery system and methods for its use for the delivery and placementof a prosthetic implant within an anatomic site. Furthermore, thedelivery system and methods according to the present invention arecapable of in situ adjustment of such a prosthetic implant following itsplacement.

An adjustable prosthetic implant according to a first aspect of thepresent invention could allow in situ adjustment after initial narrowingof the circumference of an internal anatomic passage under physiologicassessment after primary surgical closure. Such an adjustable prostheticimplant according to the present invention could be placed through anopen surgical incision, or it could be placed endoscopically, eitherpercutaneously or with an endoscope placed within a body cavity ororgan. In addition, such an adjustable prosthetic implant according tothe present invention could be coupled with an adjustment means capableof being placed in the subcutaneous or other anatomic tissues within thebody, such that remote adjustments could be made to the implant duringphysiologic function of the implant. Such an adjustment means might becapable of removal from the body, or might be retained within the bodyindefinitely for later adjustment.

The present invention and the methods for its use anticipate manyalternate embodiments in other potential applications in the broadfields of medicine and surgery. Among the other potential applicationsanticipated according to the present invention are adjustable implantsfor use in the treatment of anal incontinence, urinary incontinence,anastomotic strictures, arterial stenosis, urinary incontinence,cervical incompetence, ductal strictures, morbid obesity, and fortricuspid valvular dysfunction. The preceding discussions are intendedto be exemplary embodiments according to the present invention andshould not be construed to limit the present invention and the methodsfor its use in any way.

In another exemplary application according to the present invention, adysfunctional cardiac valve could be replaced or functionallysupplemented to relieve disease without the need for open heart surgeryby a delivery system and methods for use that would allow placement of aprosthetic heart valve by a similar percutaneous or other minimallyinvasive procedure.

Objects, features, and advantages of the present invention will becomeapparent upon reading the following specification, when taken inconjunction with the drawings and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front view of a first embodiment of an implant for reducingthe circumference of an anatomic orifice.

FIG. 2 is a front view of the implant of FIG. 1 secured to the annulusof a mitral valve, with the implant in an expanded position.

FIG. 3 is a front view of the implant of FIG. 1 secured to the annulusof a mitral valve, with the implant in a contracted position to reducedthe size of the heart valve opening.

FIG. 4 is a perspective view of a second embodiment of an implant forreducing the circumference of an anatomic orifice, inserted through anopen operative cardiac incision and secured around the mitral valve.

FIG. 5 is a perspective view of the implant of FIG. 4, showing thecardiac incision closed, an adjustment tool extending through the closedincision, and adjustment of the implant possible after the patient hasbeen taken “off pump.”

FIG. 6 is a perspective view of a first embodiment of an adjustmentmeans for adjusting the circumference of an implant for reducing thecircumference of an anatomic orifice.

FIG. 7 is a right side view of the adjustment means of FIG. 6.

FIG. 8 is a left side view of the adjustment means of FIG. 6.

FIG. 9 is a right side view of a second embodiment of an adjustmentmeans for adjusting the circumference of an implant for reducing thecircumference of an anatomic orifice.

FIG. 10 is a perspective view of a first alternate embodiment of anattachment means for the implant of FIG. 1.

FIG. 11 is a perspective view of a second alternate embodiment of anattachment means for the implant of FIG. 1.

FIG. 12 is a perspective view of a third embodiment of an implant forreducing the circumference of an anatomic orifice.

FIG. 13 is a perspective view of one end of the implant of FIG. 12showing an optional keyed relationship between three coaxial cannulae toprevent relative rotation between the three components.

FIG. 14 is a perspective view of the implant of FIG. 12 showing theouter cannula extended to cover the implant.

FIG. 15 is a perspective view of the implant of FIG. 12 showing theouter cannula retracted to expose the implant.

FIG. 16 is a perspective view of the implant of FIG. 12 showing themiddle cannula extended to unfold the implant.

FIGS. 17 and 18 are schematic views illustrating how extension of themiddle cannula causes the implant to unfold, where

FIG. 17 shows the implant in the folded position, and

FIG. 18 shows the implant in the unfolded position.

FIG. 19 is a perspective view of the lower end of a touchdown sensor ofthe implant of FIG. 12, showing the sensor in an uncompressed condition.

FIG. 20 is a perspective view of the lower end of the touchdown sensorof FIG. 19, showing the sensor in a compressed condition.

FIG. 21 is a perspective end view of a fourth embodiment of an implantfor reducing the circumference of an anatomic orifice.

FIG. 22 is a side view of the implant of FIG. 21 with the implant openedup to show its full length.

FIG. 23 is a side view of the adjustment mechanism of the implant ofFIG. 21.

FIG. 24 is a close-up view of two of the retention barbs of the implantof FIG. 21.

FIG. 25 is a front view of a fifth embodiment of an implant for reducingthe circumference of an anatomic orifice, with the implant shown in itsexpanded configuration.

FIG. 26 is a front view of the implant of FIG. 25, with the implantshown in its contracted configuration.

FIG. 27 is an enlarged view of the area indicated by the circle 27 inFIG. 25, with the outer body removed to show interior detail.

FIG. 28 is a schematic view showing the implant of FIG. 12 anatomicallypositioned at the mitral annulus in a heart with the implant in a fullyexpanded state.

FIG. 29 is a schematic view showing the implant of FIG. 12 anatomicallypositioned at the gastroesophageal opening with the implant in a fullyexpanded state.

FIG. 30 is a schematic view showing the implant of FIG. 29 implanted toreduce the circumference of the gastroesophageal opening.

DETAILED DESCRIPTION OF THE DISCLOSED EMBODIMENT

Referring now to the drawings, in which like numerals indicate likeelements throughout the several views, an exemplary implant 10comprising an implant body 15 is shown in FIG. 1. The implant body maybe provided in a shape and size determined by the anatomic needs of anintended native recipient anatomic site within a mammalian patient. Sucha native recipient anatomic site may be, by way of illustration and notby way of limitation, a heart valve, the esophagus near thegastro-esophageal junction, the anus, or other anatomic sites within amammalian body that are creating dysfunction that might be relieved byan implant capable of changing the size and shape of that site andmaintaining a desired size and shape after surgery.

The implant 10 of FIG. 1 comprises a circular implant body 15 which isprovided with adjustable corrugated sections 20 alternating withintervening grommet-like attachment means 25 having narrowedintermediate neck portions. As can be seen in FIGS. 2 and 3, the implantbody 15 may be secured to the annulus of a heart valve 30 by a fixationmeans such as a suture 35 secured over or through the attachment means25. The corrugated sections 20 fold and unfold as the circumference ofthe implant body 15 shortens or lengthens. Adjustment of the implant 10in situ may decrease the overall size of the heart valve 30, increasingthe coaptation of the valve leaflets 40, and changing the configurationfrom that shown in FIG. 2 to that shown in FIG. 3.

An additional exemplary embodiment 100 of the present invention is shownin FIGS. 4 and 5, with an open operative cardiac incision 105 in a heart110 shown in FIG. 4, and closure of the cardiac incision 105 in FIG. 5.As shown in FIG. 4, the exemplary adjustable implant 100 according tothe present invention comprises an implant body 115 with attachmentmeans 120 that allows fixation to the annulus of a mitral valve 125. Theexemplary adjustable implant 100 is further provided with an adjustmentmeans 130 that is controlled by an attached or coupled adjustment tool135. After closure of the myocardial incision 105 in FIG. 5, theadjustment tool 135 remains attached or coupled to the adjustment means130, so that the size and shape of the implant 100 may further beaffected after physiologic flow through the heart 110 is resumed, butwith the chest incision still open. Once the desired shape and functionare achieved, the adjustment tool 135 may be disengaged from theadjustment means 130 and withdrawn from the myocardial incision 105. Invarious embodiments according to the present invention, the adjustmentmeans 130 may be configured and placed to allow retention by orre-introduction of the adjustment tool 135 for adjustment followingclosure of the chest incision.

To use the implant 100 of FIGS. 4 and 5, the physician makes the openoperative incision 105 in the heart 110, as shown in FIG. 4, in theconventional manner. The implant 100, mounted at the forward end ofadjustment tool 135, is then advanced through the incision 105 andsutured to the annulus of the mitral valve 125. The adjustment tool 135is then manipulated, e.g., rotated, depending upon the design of theadjustment means 130, to cause the adjustment means to reduce the sizeof the implant body 115, and hence the underlying mitral valve 125 towhich it is sutured, to an approximate size. The myocardial incision 105can now be closed, as shown in FIG. 5, leaving the adjustment toolextending through the incision for post-operative adjustment.

Once the patient has been taken “off pump” and normal flow of bloodthrough the heart 110 has resumed, but before the chest incision hasbeen closed, further adjustments to the size of the mitral valve 125 canbe made by manipulating the adjustment tool 135.

FIGS. 6-8 show an exemplary adjustment means 200 for adjusting thecircumference of an annular implant such as the implant 100 previouslydescribed. The adjustment means 200 comprises a rack and pinion systemin which a first cam 205 with geared teeth 210 and an engagement coupler215 turns on a first axle 220. In this example, the first cam 205engages a geared rack 225 on one or more surfaces of a first band 230.The first band 230 passes between the first cam 205 and a second cam 235that turns on a second axle 240 that is joined to a second band 245. Asshown in FIG. 8, the first and second axles 220, 240 are maintained insuitable spaced-apart relation by means of a bracket 250 formed at theend of the second band 245.

The adjustment means 200 is preferably set within a hollow annularimplant 100 of the type previously described, though it is possible touse the adjustment means in a stand-alone configuration wherein thefirst and second bands 230, 245 are opposing ends of the same continuousannular structure. In either event, to adjust the length of an implantcomprising the adjustment means 200, a tool such as a hex wrench engagesthe engagement coupler 215 on the first cam 205 and rotates the firstcam in a counterclockwise direction as shown in FIG. 7, as indicated bythe arrow 255. Rotation of the first cam 205 causes the teeth 210 todrive the rack 225 to move the first band 230 toward the right, asindicated by the arrow 260 in FIG. 7. This movement of the first bandtightens the circumference of the annular implant. If the physicianinadvertently adjusts the implant too tight, reversing direction of theengagement coupler 215 will loosen the implant.

In various embodiments according to the present invention, the first andsecond bands 230, 245 may be separate structures, or they may beopposing ends of the same continuous structure. In such an embodiment,when motion is imparted to the engagement coupler 215, the first cam 205is rotated, causing the geared teeth 210 to engage the geared rack 225,and causing the first band 230 to move with respect to the second band245 to adjust the circumference of an implant.

FIG. 9 shows a somewhat different configuration of an exemplaryengagement means 300 according to the present invention, in which thereis no engagement coupler, and a bracket 350 is provided on both sides ofthe cams to maintain the first cam 315 and the second cam 320 in closeapproximation. In one proposed embodiment, the bracket is designed withclose tolerances so as to press the first band 330 closely against thesecond band 345, thereby to hold the bands in fixed relative position byfriction. In another proposed embodiment, the brackets 350 arefabricated from an elastic material such that the cams 315, 320 can bespread apart to insert the first band 330 between the cams, whereuponthe cams are pulled back together with sufficient force to hold thebands 330, 345 in fixed relative position by friction. In still anotherproposed embodiment involving an elastic mounting arrangement betweenthe cams 315, 320, the lower edge of the first band 330 and the upperedge of the second band 345 have mating frictional or mechanicalsurfaces, whereby the cams 315, 320 can be spread apart to permitrelative movement between the bands or released to clamp the bandstogether in fixed relation.

FIG. 10 shows an exemplary attachment means 400 for an implant accordingto the present invention. The attachment means 400 could be used, forexample, in place of the attachment means 25 of the implant 10. Theattachment means 400 takes the form of a grommet 410 comprising a wall415 defining a lumen 420 and an attachment surface 425. Such anattachment means would be used with the implant body extending throughthe lumen 420 and with fixation devices such as sutures or wires eithertied over or affixed through the attachment surface 425.

FIG. 11 shows another alternate embodiment of an attachment means 500for an implant according to the present invention. The attachment means500 could also be used, for example, in place of the attachment means 25of the implant 10. FIG. 11 shows an attachment means 500 in the form ofa hollow tube or tube segment 510 comprising a wall 515 defining a lumen520, an outer surface 525, and an attachment tab 530. Such an attachmentmeans would be used with the implant body extending through the lumen520 and with fixation devices such as sutures or wires either tied orotherwise affixed over or through the attachment tab 530. Such fixationdevices might be placed through holes 535 provided in the attachment tab530. Alternately a solid attachment tab 530 might be provided, and thefixation devices might be passed through the solid tab. Modifications ofthese attachment means may be used in conjunction with a suturelessattachment system.

FIGS. 12-18 show another embodiment of a percutaneous annuloplastydevice according to the present invention, in which an implant/deliverysystem array 600 includes a housing sheath 605 (not seen in FIG. 12), anactuating catheter 610 coaxially slidably mounted within the housingsheath 605, and a core catheter 615 coaxially slidably mounted withinthe actuating catheter 610. The core catheter has a central lumen 616(FIG. 13). The actuating catheter 610 and core catheter 615 may be roundtubular structures, or as shown in FIG. 13, either or both of theactuating and core catheters may be provided with one or more keyedridges 618, 620 respectively to be received by one or more reciprocalslots 622, 624 within the inner lumen of either the housing sheath 605or the actuating catheter 610, respectively. Such keyed ridges 618, 620would limit internal rotation of an inner element within an outerelement, should such restriction be desirable to maintain control of theinner contents from inadvertent displacement due to undesired rotationalmotion during use.

The implant/delivery system array 600 includes a distal tip 625 at theforward end of the core catheter 615. One or more radial implant supportarms 630 have their distal ends 632 pivotably or bendably mounted to thecore catheter 615 adjacent its distal tip 625. The proximal ends 634 ofthe radial implant support arms 630 normally extend along the corecatheter 615 but are capable of being displaced outward away from thecore catheter.

One or more radial support struts 636 have their proximal ends 638pivotably or bendably mounted to the distal end of the actuatingcatheter 610. The distal end 640 of each radial support strut is 636pivotably or bendably attached to a midpoint of a corresponding radialimplant support arm 630. As the actuating catheter 610 is advanced withrespect to the core catheter 615, the radial support struts 636 forcethe radial implant support arms 630 upward and outward in the fashion ofan umbrella frame. Thus the actuating catheter 610, core catheter 615,radial support struts 636, and radial support arms 630 in combinationform a deployment umbrella 642.

A prosthetic implant 645 is releasably attached to the proximal ends 634of the radial implant support arms 630. Around the periphery of theprosthetic implant 645 and extending proximally therefrom are aplurality of retention barbs 646. In addition, one or more of the radialimplant support arms 630 comprise touchdown sensors 648 whose proximalends extend proximal to the implant 645. Extending through the centrallumen 616 (FIG. 13) of the core catheter 615 in the exemplary embodiment600 and out lateral ports 650 (FIG. 12) spaced proximally from thedistal tip 625 are one or more release elements 660, which serve torelease the implant 645 from the delivery system, and one or moreadjustment elements 665 which serve to adjust the implant's deployedsize and effect. Because the release elements 660 and adjustmentelements 665 extend through the proximal end of the core catheter 615,as seen in FIGS. 14-16, these elements can be directly or indirectlyinstrumented or manipulated by the physician. A delivery interface 670(FIGS. 12,16) is defined in this example by the interaction of thedeployment umbrella 642, the release elements 660, and the implant 645.In the disclosed embodiment, the release elements 660 may be a suture,fiber, or wire in a continuous loop that passes through laser-drilledbores in the implant 645 and in the radial implant support arms 630, andthen passes through the length of the core catheter 615. In such anembodiment, the implant 645 may be released from the delivery system ata desired time by severing the release element 660 at its proximal end,outside the patient, and then withdrawing the free end of the releaseelement 660 through the core catheter 610.

FIGS. 14-16 show the operation of the implant/delivery system array 600,in which an umbrella-like expansion of the prosthetic implant 645 isachieved by sliding movement of the housing sheath 605, the actuatingcatheter 610, and the core catheter 615. Referring first to FIG. 14, thehousing sheath 605 is extended to cover the forward ends of theactuating catheter 610 and core catheter 615 for intravascular insertionof the implant/delivery system array 600. From this starting position,the housing sheath 605 is retracted in the direction indicated by thearrows 662. In FIG. 15 the housing sheath 605 has been retracted toexpose the forward end of the actuating catheter 610 and the collapseddeployment umbrella 642. From this position the actuating catheter 610is advanced in the direction indicated by the arrows 664. This willcause the deployment umbrellas to expand in the directions indicated bythe arrows 666. FIG. 16 shows the expansion of the deployment umbrella642 produced by distal motion of the actuating catheter 610 relative tothe core catheter 615. After the implant 645 has been positioned andadjusted to the proper size, the housing sheath 605 is advanced in thedirection indicated by the arrows 668 to collapse and to cover thedeployment umbrella 642 for withdrawal of the device from the patient.

FIGS. 17 and 18 are schematic views illustrating the radial implantsupport arms 630 and the radial support struts 636 of theimplant/delivery system array 600. In FIG. 17, a radial support strut636 is pivotably attached at its proximal end 638 at a first pivotablejoint 670 to the actuation catheter 610. The radial support strut 636 isattached at its distal end 640 to a second pivotable joint 672 at anintermediate point of a corresponding radial implant support arm 630.The radial implant support arm 630 is attached at its distal end 632 bya third pivotable joint 674 to the core catheter 620. FIG. 17 shows theassembly in a closed state. When the actuation catheter 610 is advanceddistally over the core catheter 615, as shown by the arrows 676, theradial support strut 636 and the radial implant support arm 630 areextended by the motion at the first pivotable joint 670, the secondpivotable joint 672, and the third pivotable joint 674, as shown by thearrow 678. This motion has the effect of expanding the deploymentumbrella and folded implant (not shown in FIGS. 17 and 18), allowing itto achieve its greatest radial dimension, prior to engagement andimplantation as previously discussed with reference to FIGS. 12-16.

FIGS. 19 and 20 show further details of the touchdown sensors 648 shownpreviously in FIG. 12. The touchdown sensor 648 of FIGS. 19 and 20includes a distal segment 680, an intermediate segment 682, and aproximal segment 684. The distal segment 680 is spring-mounted, so thatit is capable of slidable, telescoping displacement over theintermediate segment 682 to achieve a seamless junction with theproximal segment 684 upon maximal displacement. When the touchdownsensor 648 is in its normal condition, the spring extends the proximalsegment such that the sensor assumes the orientation shown in FIG. 19.When the implant 645 (FIG. 12) is seated against the periphery of ananatomical opening, the proximal segment 684 of the sensor 648 iscompressed against the distal segment 680, as shown in FIG. 20. Thedistal segment 680 and the proximal segment 684 are both constructed of,are sheathed by, or otherwise covered with a radio-opaque material.However, the intermediate segment 682 is not constructed or coated withsuch a radio-opaque material. Therefore, when the distal segment 680 isat rest, it is fully extended from the proximal segment 684, and the gaprepresented by the exposed intermediate segment 682 is visible onradiographic examination. However, when the distal segment 680 isbrought to maximum closeness with the proximal segment 684, no suchradio-opaque gap is radiographically visible, and the touchdown sensoris said to be “activated”. This embodiment allows radiographicmonitoring of the position of the touchdown sensor 648 with respect tothe degree of extension of the distal catheter segment 680. In theembodiment according to the present invention as shown, one or moretouchdown detectors 648 are employed to ascertain that the deliverysystem for the prosthetic device is located in the proper position todeploy the implant into the mitral annulus. As this anatomic structurecannot be directly identified on fluoroscopy or standard radiographicprocedures, such precise location could be otherwise difficult. At thesame time, precise localization and engagement of the mitral annulus iscritical for proper implant function and safety.

Touchdown detectors within the embodiments according to the presentinvention can have a multiplicity of forms, including the telescoping,spring-loaded, radio-opaque elements joined by a non-radio-opaqueelement as in the aforementioned examples. In embodiments employingmagnetic resonance imaging, touchdown detectors according to the presentinvention may utilize metallic segments interposed by nonmetallicsegments in a similar telescoping, spring-loaded array. Otherembodiments include a visually-evident system with telescoping,spring-loaded elements with color-coded or other visual features forprocedures in which direct or endoscopic observation would be possible.Still other embodiments of touchdown detectors according to the presentinvention include touchdown detectors provided with microswitches attheir tips, such that momentary contact of sufficient pressure completesan electrical circuit and signals the activation of the touchdowndetector to the operator. Still other touchdown detectors according tothe present invention are provided with fiberoptic pathways for Rahmenlaser spectroscopy or other spectral analytical techniques which arecapable of detecting unique tissue qualities of the tissue at thedesired site for implantation. In addition, still other embodimentsaccording to the present invention include touchdown detectorscontaining electrodes or other electronic sensors capable of detectingand signaling the operator when a desired electrophysiologic, impedance,or other measurable quality of the desired tissue is detected for properimplantation. Such electrophysiologic touchdown detectors may includeelectrical circuits that produce visual, auditory, or other signals tothe operator that the detectors are activated and that the implant is inthe proper position for attachment.

In yet other embodiments according to the present invention, otherintracardiac or extracardiac imaging techniques including, but notlimited to, intravascular ultrasound, nuclear magnetic resonance,virtual anatomic positioning systems, or other imaging techniques may beemployed to confirm proper positioning of the implant, obviating theneed for the touchdown sensors as previously described.

FIGS. 21-24 show an implant 700 according to one embodiment of thepresent invention. In this embodiment, the implant body 705 is bandlikeand flexible. Through much of its length, the implant body 705 isprovided with a series of retention barbs 710 which are oriented tofacilitate placement, retention, and removal of the device. The implantbody 705 is also provided with an adjustable section 715, which isprovided in this example with a series of adjustment stops 720. Theadjustment stops 720 may be slots, holes, detents, dimples, ridges,teeth, raised elements, or other mechanical features to allow measuredadjustment of the implant 700 in use. In the embodiment shown in FIGS.21-24, the adjustment stops 720 are engaged by a geared connector 725.FIG. 21 is an end view, showing the implant body 705 curved on itself,with the retention barbs 710 to the exterior, and with the adjustablesection 715 passing through its engagement with the geared connector 725and curving internally within the implant body 705 to form a closed,round structure. FIG. 23 shows details of an exemplary geared connector725, in which a housing 730 is connected to the implant body 705. Thehousing 730 contains and supports a mechanical worm 740 with an attachedfirst geared head 750 which mates with a second geared head 755. Thesecond geared head 755 is attached to an adjustment stem 760 which ismachined to receive a screwdriver-like adjustment element. The variousembodiments according to the present invention may require a number offorms of adjustment elements. In the present example, the adjustmentelement is provided as a finely coiled wire with a distal tip machinedto be received by a receiving slot in the adjustment stem 760 (notshown). The relationship between the distal tip of the adjustmentelement and the adjustment stem 760 is mechanically similar to ascrewdriver bit and screwhead, such that torsion imparted to theadjustment means by the operator will result in the turning of theadjustment stem 760 and second geared head 755 allows motion of thefirst geared head 750 and worm 740, which creates motion of theadjustable implant section 715 as the worm engages with the series ofadjustment tops 725. Excess length of the adjustable section 715 passesthough a band slot 735 (FIG. 23), thus allowing the band to moveconcentrically inside the closed implant body 705. The adjustmentelement in this embodiment may be designed to remain in place after thedeployment umbrella has been retracted and withdrawn. The connectionbetween the adjustment element's distal tip and the adjustment stem 760may be a simple friction connection, a mechanical key/slot formation, ormay be magnetically or electronically maintained.

As further shown in FIG. 21, the exemplary embodiment employsunidirectional retention barbs 710 which are attached to the outerperimeter of the implant body 705. The retention barbs 710 are orientedin a consistent, tangential position with respect to the implant body705 such that rotational motion of the implant body will either engageor release the retention barbs 710 upon contact with the desired tissueat the time of deployment. This positioning of the retention barbs 710allows the operator to “screw in” the implant 700 by turning the implant700 upon its axis, thus engaging the retention barbs 710 into theadjacent tissue. As shown in FIG. 24, the retention barbs 710 may eachbe further provided with a terminal hook 775 at the end which wouldallow for smooth passage through tissue when engaging the retentionbarbs 710 by rotating the implant 700, without permitting the implant700 to rotate in the opposite direction, because of the action of theterminal hooks 775 grasping the surrounding tissue (much like barbedfish hooks). The terminal hooks 775 thus ensure the seating of theimplant 700 into the surrounding tissue.

FIGS. 25-27 illustrate another embodiment of an implant 800 ascontemplated according to the present invention. The implant 800includes a band 805 (FIG. 27), but the retention barbs of the previousexample have been eliminated in favor of an outer fabric implant sheath810. The fabric sheath 810 can be sutured or otherwise affixed to theanatomic tissue in a desired location. The circumference of the implantbody 800 is adjusted through a geared connector 825 similar to thegeared connector of the bandlike implant array shown in FIG. 23. Morespecifically, adjustment stops 820 on the band are engaged by amechanical worm 840 with an attached first geared head 850. The firstgeared head 850 mates with a second geared head 855. The second gearedhead 855 is attached to an adjustment stem 860 which is machined toreceive a screwdriver-like adjustment element.

FIG. 28 illustrates an example of the method of use of animplant/delivery system array 600 for positioning an implant 645 in apatient with ischemic annular dilatation and mitral regurgitation.Peripheral arterial access is obtained via conventional cutdown,arterial puncture, or other standard access techniques. After access tothe arterial system is attained, guidewire placement is performed andintravascular access to the heart 900 is obtained using fluoroscopic,ultrasound, three-dimension ultrasound, magnetic resonance, or otherreal-time imaging techniques. The guidewire, deployment device, andimplant are passed through the aortic valve in a retrograde fashion intothe left ventricle 905 and then into the left atrium 910. At this point,the operator retracts the housing sheath 605, thus unsheathing thecollapsed deployment umbrella 642 and implant 645. The deploymentumbrella 642 is then distended by the distal motion of the actuationcatheter, causing the radial support arms and struts to fully distend.At this point, the touchdown detectors 648 are not in contact with anysolid structures, and are fully extended with their radiolucent gapsvisible on the imaging system. Once the deployment umbrella isdistended, the entire assembly is pulled back against the area of themitral valve 915. At least two touchdown detectors 648 are employed in apreferred embodiment according to the present invention. When alltouchdown detectors show the disappearance of their intermediate,non-opaque, intermediate segments and are thus activated, then thedeployment umbrella must be in contact with the solid tissue in theregion of the mitral annulus/atrial tissue, and further implantdeployment and adjustment may proceed. However, if any one touchdownsensor is not activated, and a radiolucent gap persists, then the deviceis not properly positioned, and must be repositioned before furtherdeployment. Thus, the touchdown sensor system may assist in thedeployment and adjustment of prosthetic devices by the delivery systemaccording to the present invention. Once properly positioned, theoperator rotates the actuation catheter in a prescribed clockwise orcounterclockwise manner to engage the retention barbs on the implantinto the tissue in the region of the mitral annulus/atrial tissue.Should re-positioning be required, a reverse motion would disengage theretention barbs from the annular/atrial tissue, and repositioning may beperformed, again using the touchdown detectors for proper placement.Once firmly seated, the adjustment element(s) are operated to achievethe desired degree of annular reduction. Real-time trans esophagealechocardiography, intravascular echocardiography, intracardiacechocardiography, or other modalities for assessing mitral function maythen be employed to assess the physiologic effect of the repair onmitral function, and additional adjustments may be performed. Once adesired result has been achieved, the release elements are activated todetach the implant from the deployment umbrella. The operator thenretracts the actuation catheter and extends the housing sheath,collapsing the deployment umbrella and covering the components for asmooth and atraumatic withdrawal of the device from the heart andvascular system.

If desired, the adjustment elements may be left in position after thecatheter components are withdrawn for further physiologic adjustment. Inyet other embodiments according to the present invention, acatheter-based adjustment elements may subsequently be re-insertedthough a percutaneous or other route. Such an adjustment element may besteerably operable by the operator, and may be provided with magnetic,electronic, electromagnetic, or laser-guided systems to allow docking ofthe adjustment element with the adjustable mechanism contained withinthe implant. In still other embodiments, the adjustment mechanism may bedriven by implanted electromechanical motors or other systems, which maybe remotely controlled by electronic flux or other remote transcutaneousor percutaneous methods.

In the case of pulmonic valve repair, initial catheter access isachieved through a peripheral or central vein. Access to the pulmonaryvalve is also achieved from below the valve once central venous accessis achieved by traversing the right atrium, the tricuspid valve, theright ventricle, and subsequently reaching the pulmonic valve.

In yet other embodiments according to the present invention, catheteraccess to the left atrium can be achieved from cannulation of central orperipheral veins, thereby achieving access to the right atrium. Then astandard atrial trans-septal approach may be utilized to access the leftatrium by creation of an iatrogenic atrial septal defect (ASD). In sucha situation, the mitral valve may be accessed from above the valve, asopposed to the retrograde access described in Example 1. The implant anda reversed deployment umbrella may be utilized with implant placement inthe atrial aspect of the mitral annulus, with the same repair techniquedescribed previously. The iatrogenic ASD may then be closed usingstandard device methods. Access to the aortic valve may also be achievedfrom above the aortic valve via arterial access in a similar retrogradefashion.

Other embodiments of the adjustable implant and methods according to thepresent invention include gastrointestinal disorders such asgastro-esophageal reflux disease (GERD), a condition in which thegastro-esophageal (GE) junction lacks adequate sphincter tone to preventthe reflux of stomach contents into the esophagus, causing classicheartburn or acid reflux. This not only results in discomfort, but maycause trauma to the lower esophagus over time that may lead to thedevelopment of pre-cancerous lesions (Barrett's esophagus) oradenocarcinoma of the esophagus at the GE junction. Surgical repair ofthe GE junction has historically been achieved with the NissenFundoplication, an operative procedure with generally good results.However, the Nissen procedure requires general anesthesia and a hospitalstay. Utilizing the devices and methods according to the presentinvention, an adjustable implant would obviate the need for a hospitalstay and be performed in a clinic or gastroenterologist's office.Referring now to FIGS. 29 and 30, an umbrella deployment device 600 withimplant 645 is passed under guidance of an endoscope 1000, through thepatient's mouth, esophagus 1005, and into the stomach 1010, where thedeployment device 600 is opened with expansion of the implant 645 andtouchdown detectors 648 with a color-coded or otherwise visible gap. Thetouchdown detectors are then engaged onto the stomach around thegastroesophageal junction 1015 under direct endoscopic control until alltouchdown detectors 648 are visually activated. The implant is thenattached to the stomach wall, 1020 the umbrella 642 is released andwithdrawn, leaving behind the implant 645 and the adjustment elements.The implant is then adjusted until the desired effect is achieved, i.e.,minimal acid reflux either by patient symptoms, pH monitoring of theesophagus, imaging studies, or other diagnostic means. If the patientshould suffer from gas bloat, a common complication of gastroesophagealjunction repair in which the repair is too tight and the patient isunable to belch, the implant can be loosened until a more desirableeffect is achieved.

In various embodiments anticipated by the present invention, the implantbody may be straight, curved, circular, ovoid, polygonal, or somecombination thereof. In various embodiments anticipated by the presentinvention the implant may be capable of providing a uniform ornon-uniform adjustment of an orifice or lumen within the body. Theimplant body may further completely enclose the native recipientanatomic site, or it may be provided in an interrupted form thatencloses only a portion of the native recipient anatomic site. In stillother embodiments of the present invention, the implant body may be asolid structure, while in yet other embodiments the implant body mayform a tubular or otherwise hollow structure. In one embodiment of thepresent invention, the body may further be a structure with an outermember, an inner member, and optional attachment members. In such anembodiment, the outer member of the implant body may serve as a coveringfor the implant, and is designed to facilitate and promote tissueingrowth and biologic integration to the native recipient anatomic site.The outer member in such an embodiment may be fabricated of abiologically compatible material, such as Dacron, PTFE, malleablemetals, other biologically compatible materials or a combination of suchbiologically compatible materials in a molded, woven, or non-wovenconfiguration. The outer member in such an embodiment also serves tohouse the inner member. In this embodiment, the inner member provides anadjustment means that, when operated by an adjustment mechanism, iscapable of altering the shape and/or size of the outer member in adefined manner.

In alternate embodiments according to the present invention, theadjustment means may be located external to or incorporated within theouter member. In yet additional alternate embodiments contemplated bythe present invention, the implant body may consist of an adjustmentmeans without a separate outer member covering said adjustment means.

In various embodiments according to the present invention, theadjustment means may include a mechanism which may be threaded ornon-threaded, and which may be engaged by the action of a screw or wormscrew, a friction mechanism, a friction-detent mechanism, a toothedmechanism, a ratchet mechanism, a rack and pinion mechanism, or suchother devices to permit discreet adjustment and retention of desiredsize a desired position, once the proper size is determined.

In yet other embodiments according to the present invention, theadjustment means may comprise a snare or purse string-like mechanism inwhich a suture, a band, a wire or other fiber structure, braided ornon-braided, monofilament or multifilament, is capable of affecting theanatomic and/or physiologic effects of the implant device on a nativeanatomic recipient site upon varying tension or motion imparted to saidwire or fiber structure by a surgeon or other operator. Such anadjustment means may be provided as a circular or non-circular structurein various embodiments. Changes in tension or motion may change the sizeand/or shape of the implant.

In various embodiments according to the present invention, theadjustment means may be a metallic, plastic, synthetic, natural,biologic, or any other biologically-compatible material, or combinationthereof. Such adjustment means may further be fabricated by extrusion orother molding techniques, machined, or woven. Furthermore, in variousembodiments of the present invention, the adjustment means may be smoothor may include slots, beads, ridges, or any other smooth or texturedsurface.

In various embodiments of the present invention, the implant body may beprovided with one or more attachment members such as grommets oropenings or other attachment members to facilitate attachment of theimplant to the native recipient site. In alternate embodiments, theimplant body may attach to or incorporate a mechanical tissue interfacesystem that allows a sutureless mechanical means of securing the implantat the native recipient site. In still other alternate embodiments,sutures or other attachment means may be secured around or through theimplant body to affix the implant body to the native recipient site. Inyet other embodiments of the present invention, mechanical means ofsecuring the implant body to the native recipient site may be augmentedor replaced by use of fibrin or other biologically-compatible tissueglues or similar adhesives.

In additional various embodiments according to the present invention,the adjustable implant may be employed to adjustably enlarge or maintainthe circumference or other dimensions of an orifice, ostium, lumen, oranastomosis in which a disease process tends to narrow or constrict suchcircumference or other dimensions.

In various embodiments according to the present invention, an adjustmentmechanism may be provided to interact with the adjustment means toachieve the desired alteration in the size and/or position of theadjustment means. Such an adjustment mechanism may include one or morescrews, worm-screw arrays rollers, gears, frictional stops, afriction-detent system, ratchets, rack and pinion arrays,micro-electromechanical systems, other mechanical or electromechanicaldevices or some combination thereof.

In some embodiments as contemplated by the present invention, anadjustment tool may be removably or permanently attached to theadjustment mechanism and disposed to impart motion to the adjustmentmechanism and, in turn, to the adjustment means to increase or decreasethe anatomic effect of the implant on the native recipient site.

In alternate embodiments according to the present invention, micromotorarrays with one or more micro-electromechanical motor systems withrelated electronic control circuitry may be provided as an adjustmentmeans, and may be activated by remote control through signals convey byelectromagnetic radiation or by direct circuitry though electronicconduit leads which may be either permanently or removably attached tosaid micromotor arrays.

In still other various embodiments according to the present invention,the adjustment mechanism may be provided with a locking mechanismdisposed to maintain the position of the adjustment means in a selectedposition upon achievement of the optimally desired anatomic and/orphysiologic effect upon the native recipient site and the bodily organto which it belongs. In other embodiments, no special locking mechanismmay be necessary due to the nature of the adjustment means employed.

In yet other alternate embodiments according to the present invention,the adjustment means and/or the outer member structure may be a pliablesynthetic material capable of rigidification upon exposure toelectromagnetic radiation of selected wavelength, such as ultravioletlight. In such embodiments, exposure to the desired electromagneticradiation may be achieved by external delivery of such radiation to theimplant by the surgeon, or by internal delivery of such radiation withinan outer implant member using fiberoptic carriers placed within saidouter member and connected to an appropriate external radiation source.Such fiberoptic carriers may be disposed for their removal in whole orin part from the outer implant member after suitable radiation exposureand hardening of said adjustment means.

The present invention also provides methods of using an adjustableimplant device to selectively alter the anatomic structure and/orphysiologic effects of tissues forming a passageway for blood, otherbodily fluids, nutrient fluids, semi-solids, or solids, or wastes withina mammalian body. Various embodiments for such uses of adjustableimplants include, but are not limited to, open surgical placement ofsaid adjustable implants at the native recipient site through an opensurgical incision, percutaneous or intravascular placement of saidimplants under visual control employing fluoroscopic, ultrasound,magnetic resonance imaging, or other imaging technologies, placement ofsaid implants through tissue structural walls, such as the coronarysinus or esophageal walls, or methods employing some combination of theabove techniques. In various embodiments as contemplated by the presentinvention, adjustable implants may be placed and affixed in position ina native recipient anatomic site by trans-atrial, trans-ventricular,trans-arterial, trans-venous (i.e., via the pulmonary veins) or otherroutes during beating or non-beating cardiac surgical procedures orendoscopically or percutaneously in gastrointestinal surgery.

Furthermore, alternate methods for use of an adjustable implant devicemay provide for the periodic, post-implantation adjustment of the sizeof the anatomic structure receiving said implant device as needed toaccommodate growth of the native recipient site in a juvenile patient orother changes in the physiologic needs of the recipient patient.

Adjustment of the adjustable implants and the methods for their use asdisclosed herein contemplates the use by the surgeon or operator ofdiagnostic tools to provide an assessment of the nature of adjustmentneeded to achieve a desired effect. Such diagnostic tools include, butare not limited to, transesophageal echocardiography, echocardiography,diagnostic ultrasound, intravascular ultrasound, virtual anatomicpositioning systems integrated with magnetic resonance, computerizedtomographic, or other imaging technologies, endoscopy, mediastinoscopy,laparoscopy, thoracoscopy, radiography, fluoroscopy, magnetic resonanceimaging, computerized tomographic imaging, intravascular flow sensors,thermal sensors or imaging, remote chemical or spectral analysis, orother imaging or quantitative or qualitative analytic systems.

In one aspect, the implant/delivery system of the present inventioncomprises a collapsible, compressible, or distensible prosthetic implantand a delivery interface for such a prosthetic implant that is capableof delivering the prosthetic implant to a desired anatomic recipientsite in a collapsed, compressed, or non-distended state, and thenallowing controlled expansion or distension and physical attachment ofsuch a prosthetic implant by a user at the desired anatomic recipientsite. Such a system permits the delivery system and prosthetic implantto be introduced percutaneously through a trocar, sheath, via Seldingertechnique, needle, or endoscopically through a natural bodily orifice,body cavity, or region and maneuvered by the surgeon or operator to thedesired anatomic recipient site, where the delivery system andprosthetic implant may be operably expanded for deployment. Whendesirable, the implant/delivery system according to the presentinvention is also capable of allowing the user to further adjust thesize or shape of the prosthetic implant once it has been attached to thedesired anatomic recipient site. The delivery system according to thepresent invention is then capable of detaching from its interface withthe prosthetic implant and being removed from the anatomic site by theoperator. The delivery system and prosthetic implant may be provided ina shape and size determined by the anatomic needs of an intended nativerecipient anatomic site within a mammalian patient. Such a nativerecipient anatomic site may be a heart valve, the esophagus near thegastro-esophageal junction, the anus, or other anatomic sites within amammalian body that are creating dysfunction that might be relieved byan implant capable of changing the size and shape of that site andmaintaining a desired size and shape after surgery.

In various embodiments contemplated by the present invention, thedelivery system may be a catheter, wire, filament, rod, tube, endoscope,or other mechanism capable of reaching the desired recipient anatomicsite through an incision, puncture, trocar, or through an anatomicpassageway such as a vessel, orifice, or organ lumen, ortrans-abdominally or trans-thoracically. In various embodimentsaccording to the present invention, the delivery system may be steerableby the operator. The delivery system may further have a deliveryinterface that would retain and convey a prosthetic implant to thedesired recipient anatomic site. Such a delivery interface may beoperably capable of distending, reshaping, or allowing the independentdistension or expansion of such a prosthetic implant at the desiredrecipient anatomic site. Furthermore, such a delivery interface mayprovide an operable means to adjust the distended or expanded size,shape, or physiologic effect of the prosthetic implant once said implanthas been attached in situ at the desired recipient anatomic site. Invarious embodiments according to the present invention, such adjustmentmay be carried out during the procedure in which the implant is placed,or at a subsequent time. Depending upon the specific anatomic needs of aspecific application, the delivery interface and the associatedprosthetic implant may be straight, curved, circular, helical, tubular,ovoid, polygonal, or some combination thereof. In still otherembodiments of the present invention, the prosthetic implant may be asolid structure, while in yet other embodiments the prosthetic implantmay form a tubular, composite, or otherwise hollow structure. In oneembodiment of the present invention, the prosthetic implant may furtherbe a structure with an outer member, an inner member, and optionalattachment members. In such an embodiment, the outer member of theprosthetic implant may serve as a covering for the implant, and isdesigned to facilitate and promote tissue ingrowth and biologicintegration to the native recipient anatomic site. The outer member insuch an embodiment may be fabricated of a biologically compatiblematerial, such as Dacron, PTFE, malleable metals, other biologicallycompatible materials or a combination of such biologically compatiblematerials in a molded, woven, or non-woven configuration. The outermember in such an embodiment also serves to house the inner member. Inthis embodiment, the inner member provides an adjustment means that,when operated by an adjustment mechanism, is capable of altering theshape and/or size of the outer member in a defined manner.

In some embodiments according to the present invention, at least someportions of the adjustable inner or outer member may be elastic toprovide an element of variable, artificial muscle tone to a valve,sphincter, orifice, or lumen in settings where such variability would befunctionally valuable, such as in the treatment of rectal incontinenceor vaginal prolapse.

In various embodiments according to the present invention, the deliveryinterface would have an attachment means to retain and convey theprosthetic implant en route to the native anatomic recipient site andduring any in situ adjustment of the prosthetic implant once it has beenplaced by the operator. Such an attachment means would be operablyreversible to allow detachment of the prosthetic implant from thedelivery interface once desired placement and adjustment of theprosthetic implant has been accomplished.

Finally, it will be understood that the preferred embodiment has beendisclosed by way of example, and that other modifications may occur tothose skilled in the art without departing from the scope and spirit ofthe appended claims.

The invention claimed is:
 1. A prosthetic annulus delivery systemcomprising: a foldable annuloplasty annular ring configured to have afolded configuration and an un-folded configuration; an expansionassembly comprising an expansion member removably connected to saidfoldable annular ring when in said folded configuration and saidun-folded configuration, and an actuating catheter connected to saidexpansion member; an outer catheter coaxially slideably mounted oversaid expansion assembly between a first position covering said expansionassembly and a second position uncovering said expansion assembly, saidcatheter having a forward end adapted to receive therein said foldableannular ring and said expansion member when said catheter is arranged insaid first position and said annular ring is in said foldedconfiguration, and wherein said expansion assembly is adapted to unfoldsaid annular ring and expel said annular ring from within said forwardend of said catheter when said catheter is arranged in said secondposition uncovering said expansion assembly and said annular ring; and amechanical tissue interface system, wherein said foldable annular ringis adapted to be secured to tissue adjacent said foldable annular ringwhen said foldable annular ring is unfolded and wherein said mechanicaltissue interface system is configured to respond to an applied force toadhere to the adjacent tissue.
 2. The system of claim 1, wherein saidannular ring is adapted to fit in a mitral valve opening of a heart. 3.The system of claim 1, wherein said annular ring is adapted to fit in anaortic valve opening of a heart.
 4. The system of claim 1, wherein saidannular ring is adapted to fit in a pulmonary valve opening of a heart.5. The system of claim 1, wherein said annular ring is adapted to fit ina tricuspid valve opening of a heart.
 6. The system of claim 1, whereinsaid mechanical tissue interface system comprises retention barbs. 7.The system of claim 1, wherein said expansion member comprises implantsupport arms that expand to deploy said folded annular ring to a radialdimension.
 8. The system of claim 1, wherein said annular ring isradially expandable.
 9. The system of claim 1, wherein said annular ringand said mechanical tissue interface system are integrated into aone-piece design.
 10. The system of claim 1, wherein said annuloplastyannular ring includes a flexible band.
 11. A prosthetic annulus deliverysystem comprising: a foldable annuloplasty annular ring having a foldedconfiguration and an unfolded configuration; an expansion assemblycomprising an expansion member removeably coupled to the annular ringwhen in both a folded and unfolded configuration, and an actuatingcatheter connected to said expansion member; an outer catheter coaxiallyslideably mounted over said expansion assembly between a first positioncovering said expansion assembly and a second position uncovering saidexpansion assembly, said catheter having a forward end adapted toreceive therein said foldable annular ring and said expansion memberwhen said catheter is arranged in said first position and said annularring is in said folded configuration, and wherein said expansionassembly is adapted to unfold said annular ring and expel said annularring from within said forward end of said catheter when said catheter isarranged in said second position uncovering said expansion assembly andsaid annular ring; a core catheter slideably mounted within theactuating catheter and having a forward end connected to said expansionmember; and a mechanical tissue interface system adapted for securingthe annular ring in the unfolded configuration to tissue adjacentthereto.
 12. A prosthetic annulus delivery system comprising: a foldableannuloplasty annular ring having a folded configuration and an unfoldedconfiguration, the annular ring adapted to be attached to tissueadjacent an anatomical lumen or orifice; an expansion assemblycomprising a radial expansion member adapted to be removeably coupled tothe annular ring when both in the folded configuration and the unfoldedconfiguration, and an actuating catheter coupled to the expansionmember; a longitudinal outer catheter coaxially slideably mounted overthe expansion assembly, the catheter having a forward end adapted tocapture internally therein the annular ring when in the foldedconfiguration and the expansion member attached to the annular ring whenin the folded configuration, wherein the actuating catheter is adaptedto unfold the annular ring radially from the folded configuration whenthe expansion member is exposed by moving the actuating catheterlongitudinally relative to the outer catheter and expelling the annularring from within the catheter; and an adjustment tool adapted to bereleasably coupled to the annular ring when in the folded and unfoldedconfiguration for adjusting the size of the annular ring when in theunfolded configuration.
 13. The system of claim 12, wherein theexpansion member comprises implant support arms that expand to deploythe folded annular ring to a radial dimension.
 14. The system of claim12, further including a core catheter slideably mounted within theactuating catheter and having a forward end connected to said expansionmember.
 15. The system of claim 1, further including a core catheterslideably mounted within the actuating catheter and having a forward endconnected to said expansion member.
 16. A prosthetic annulus deliverysystem for a foldable annuloplasty annular ring, comprising: a foldableannuloplasty annular ring having a folded configuration and an un-foldedconfiguration, the annular ring adapted to be attached to tissueadjacent an anatomical orifice or lumen; a longitudinal catheter havinga hollow interior; an expansion assembly coaxially slideably mountedwithin the interior of the catheter, the expansion assembly removeablycoupled to the annular ring when in both the folded configuration andthe un-folded configuration, wherein the expansion assembly is moveablerelative to the catheter from a first position wherein the expansionassembly and the annular ring in the fold configuration are arrangedwithin the interior of the catheter, and a second position wherein theexpansion assembly and the annular ring in the un-folded configurationare arranged outside the interior of the catheter; and an adjustmenttool adapted to be releasably coupled to the annular ring for adjustingat least one of the size and shape of the annular ring.
 17. The systemof claim 16, wherein the expansion assembly includes an expansion memberattached to the annular ring, an actuating catheter attached to theexpansion member and having a hollow interior, and a core catheterslideable mounted within the interior of the actuating catheter andattached to the expansion member.